Clinical Trial: Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without a Cervical Disc Prosthesis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without an Activ-C Cervical Disc Prosthesis.

Brief Summary: The purpose of this study is to find out if use of a cervical disc prosthesis in the treatment of a cervical disc herniation preserves or restores normal mobility and movement in the cervical spine.

Detailed Summary:

Intractable nerve pain to the arm caused by a cervical disc herniation is typically treated by removal of the protruding disc through an operation. Fusion of the discs follows in about 70% of cases.

Adjacent disc disease (ADD), symptomatic degenerative changes in the levels adjacent to the operated level is regarded as a late complication. Fusion at the operated level is thought to contribute to this process due to compensative increased mobility and stress on the adjacent segments.

Keeping the operated segment mobile through the use of a cervical disc prosthesis possibly prevents ADD.

We hypothesize that use of a cervical disc prosthesis preserves or restores normal mobility to the cervical spine. To test this hypothesis subjects are randomised in a group receiving a standard anterior cervical discectomy, and a group receiving a standard discectomy with placement of a cervical disc prosthesis. Digital X-ray cinematographic videos are made of a flexion/extension movement. The videos will be analyzed manually and through a newly designed automated program, to check for mobility and order of movement.


Sponsor: Maastricht University Medical Center

Current Primary Outcome:

  • Order of movement [ Time Frame: baseline, 3 months, 12 months ]
  • Segmental mobility [ Time Frame: Baseline, 3 months, 12 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Treatment of symptoms (pain, neurological assessment) [ Time Frame: Baseline, 3 months, 12 months ]
  • Influence on subjects functioning (social, work) [ Time Frame: Baseline, 3 months, 12 months ]


Original Secondary Outcome: Same as current

Information By: Maastricht University Medical Center

Dates:
Date Received: March 23, 2009
Date Started: December 2007
Date Completion:
Last Updated: March 20, 2016
Last Verified: March 2016